Daratumumab

iStock, z_wei Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession. Genmab faces an unprecedented situation. Nearing the loss of a revenue source that accounts for 90% of its sales, the company is approaching arguably the largest cliff that any company has ever faced in the pharma industry, Tahamtan Ahmadi, chief medical officer and head of experimental medicines at Genmab, told BioSpace . And a series of readouts this quarter could foreshadow whether the company will grow beyond the cliff. Two clinical wins earlier this month have set the stage with two more readouts still expected by the end of the year. Today, Genmab relies heavily on royalties from Darzalex, its Johnson & Johnson–partnered cancer drug whose U.S. patents expire in 2029. Genmab lost cases that could have softened the drop in revenues as these patents run out, creating a steep cliff. The biotech’s Darzalex revenues could fall from about $3.3 billion in 2028 to under $1 billion by 2031, and to roughly zero by 2032, Raghuram Selvaraju, managing director of Healthcare Equity Research at H.C. Wainwright, told BioSpace by email. Despite that, the analyst believes Genmab can emerge from the trough years of 2029 and 2030 in a strong position. “We think Genmab has more than enough horsepower under the hood to overcome the almost total loss of revenue from Darzalex,” Selvaraju said. “Genmab’s ability to weather this challenge depends on three wholly owned or partnered oncology assets.” The company recently shared positive data on two of the three assets. In the first week of October, Genmab reported Phase 3 findings from the AbbVie-partnered Epkinly in first-line lymphoma that analysts said could potentially set “the new standard of care” in this indication and posted “durable and clinically meaningful” Phase 2 results for the antibody-drug conjugate (ADC) rinatabart sesutecan (Rina-S) in ovarian cancer. Genmab expects Phase 3 Rina-S data this year, but Selvaraju now sees data on the third asset, petosemtamab, as the only “binary event risk.” Lymphoma AbbVie, Genmab’s Epkinly sets ‘new standard of care’ in first-line lymphoma in Phase 3 AbbVie and Genmab’s bispecific antibody blew analyst expectations out of the water with a 51% improvement in progression-free survival when used alongside a standard frontline regimen in diffuse large B cell lymphoma—potentially setting up a battle with Roche’s Polivy. October 6, 2026 · 3 min read · Tristan Manalac Read more Genmab’s big bet Genmab acquired petosemtamab, a bispecific antibody targeting EGFR and LGR5, last year in its $8 billion takeover of Merus. Among Genmab’s three key assets, “petosemtamab matters the most,” Selvaraju said. That view reflects a sales ramp that could make the bispecific a blockbuster by 2029, the year Darzalex’s U.S. patents expire, as well as possible launches in additional indications. The lead indication for petosemtamab is head and neck squamous cell carcinoma (HNSCC). Genmab expects to share results from the Phase 3 LiGeR-HN1 trial in patients with first-line HNSCC by the end of the year. In May 2025, Merus reported a 63% overall response rate (ORR) in a Phase 2 study, far surpassing the 19% Merck’s Keytruda achieved in the Phase 3 KEYNOTE-048 study—a result noted by both Selvaraju and Genmab’s Ahmadi. Achieving a 40-point or greater improvement in ORR, a co-primary endpoint in the Phase 3 trial, “would support accelerated approval and fast uptake,” Selvaraju said. Beyond that, Genmab would need to show that the increased response rate translates into improved progression-free (PFS) and overall survival (OS), the latter the study’s other primary outcome measure. PFS is a secondary endpoint. Ahmadi outlined how ORR could predict PFS and OS. “If you have a dramatic ORR difference, and the durability is good, it almost has to translate into a statistical or near-statistical PFS difference. And then, of course, it has to translate into separation in the OS curves, because otherwise it would have a safety liability,” the CMO said. Business Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more New data for Genmab and AbbVie’s bispecific antibody Epkinly wowed analysts and could set the partners up for an expanded approval in diffuse large B cell lymphoma; deals have flowed steadily this week, including Novartis’ nearly $8 billion bet on mRNA drugs with China’s Abogen Biosciences; and could Sarepta Therapeutics turn things around from last year’s annus horribilis? October 7, 2026 · 2 min read · Jef Akst Read more ADC nears key readout LiGeR-HN1 is one of two remaining Phase 3 readouts for Genmab assets this year. The biotech also plans to share data from RAINFOL-02 , which is testing its FRα-directed ADC Rina-S in platinum-resistant ovarian cancer (PROC). The readout is “relatively risk-mitigated because of the positive Phase 1/2 RAINFOL-01 data in PROC,” Selvaraju said. The Phase 1/2 clinical trial linked Rina-S to a median PFS of 9.5 months, hitting a secondary endpoint. AbbVie’s rival FRα-directed ADC Elahere achieved a median PFS of 5.6 months in the Phase 3 MIRASOL trial. Chemotherapy is the control treatment in RAINFOL-02. Based on the earlier data on Rina-S and chemotherapy, the RAINFOL-02 readout could be “very positive on PFS and potentially even on OS,” Ahmadi said. A positive PFS outcome—the trial’s primary endpoint—is “highly likely, with interim OS success (a higher bar) being possible in an upside scenario,” Guggenheim Securities analysts said in an Oct. 4 note to investors. Analysts are also looking for Genmab to replicate the breadth of efficacy seen in the Phase 1/2 trial, when the biotech reported activity in patients with low or no FRα expression. Securing a label across FRα levels would double the addressable population compared to Elahere, Selvaraju said. The analyst sees the FRα labeling terms as the variable that will determine the slope of the ramp for Rina-S sales. The competitive landscape amplifies the value of launching and growing Rina-S quickly. Rina-S is part of a wave of ADCs that use topoisomerase-1 (TOPO-1) inhibitors to treat ovarian cancer. Once a patient progresses after receiving one TOPO-1 ADC, they are unlikely to benefit from another treatment with the same payload, Ahmadi said. The importance of becoming the first-choice TOPO-1 ADC is encouraging speed and secrecy. “We are not pre-announcing these studies anymore. We basically make them public at the time the first patient gets dosed,” Ahmadi said. “It is competitive and everybody’s looking over everybody’s shoulder and copying everybody’s strategy.” Competing commercially Victories in LiGeR-HN1 and RAINFOL-02 would establish petosemtamab and Rina-S alongside Epkinly as drugs that can power Genmab through and beyond the Darzalex cliff. Yet positive data will only be a step toward the sales Genmab needs to mitigate the loss of royalties from the drug. Genmab also needs to achieve regulatory and commercial successes, and it is facing those challenges solo. The market “is still a little bit skeptical” about Genmab’s prospects in this respect, Ahmadi acknowledged. Genmab is entering “a hypercompetitive environment” and biotechs always face questions about whether they can compete commercially with larger rivals, he added. Ahmadi sees Epkinly’s success as evidence that Genmab can rise to the challenge. Working with AbbVie, Genmab has turned Epkinly into a challenger to Roche, a company that “owned” the market for 25 years with Polivy and Rituxan, Ahmadi said. Through that process, Genmab has built commercial and operational capabilities that could benefit petosemtamab and Rina-S. “We’ve been beating [Roche’s Columvi] quarter for quarter for quarter,” Ahmadi said. “I think that is a little bit unappreciated: how good we have become in running these trials, speeding up development, and how competitive we already are as a company.”

If approved, TALVEY ® plus daratumumab will be the only GPRC5D-targeting bispecific antibody combination therapy for relapsed or refractory multiple myeloma as early as second line CHMP recommendation based on Phase 3 results where talquetamab and daratumumab, with or without pomalidomide, showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months 1 BEERSE, BELGIUM, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the approval of an indication extension of TALVEY ® (talquetamab). The recommendation is for talquetamab plus daratumumab with or without pomalidomide for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), who have received at least one prior therapy. Combination of talquetamab plus daratumumab offers a novel target approach to RRMM treatment, with potential to spare healthy immune cells Talquetamab targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body). 2 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-cells . 2 Talquetamab works by targeting myeloma cells while largely sparing healthy B-cells. 2 With daratumumab priming the immune system for enhanced talquetamab activity, the combination benefits from complementary mechanisms of action, reinforcing the potential effectiveness of this approach in multiple myeloma. 2 , 3 , 4 Expert and company perspectives support talquetamab use earlier in the treatment pathway “MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a critical point in their treatment journey. This CHMP recommendation reflects the continued evolution of the talquetamab programme in multiple myeloma, and further strengthens the potential of talquetamab-based therapies as early as second line, building on our commitment to generate data that can help inform treatment choices based on patients’ prior therapies and disease characteristics.” “At Johnson & Johnson, our strategy is grounded in pursuing differentiated immunotherapy approaches earlier in the disease course to address diverse patient characteristics and the evolving complexity of multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “This off-the-shelf, immunotherapy-based combination leverages the power of our portfolio by bringing together talquetamab with the well-established therapy of daratumumab. By simultaneously targeting GPRC5D and CD38, our goal is to deliver deeper and longer lasting responses for patients.” Talquetamab combination has delivered significant clinical benefits from second line The MonumenTAL-3 study evaluated talquetamab plus daratumumab (Tal-D) or Tal-D and pomalidomide (Tal-DP) compared to daratumumab plus pomalidomide and dexamethasone (DPd) in patients with RRMM who have received at least one prior line of therapy. 5 At a median follow-up of two years (24.6 months), results showed significant improvement in progression-free survival (PFS) for Tal-DP (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.20-0.40; p <0.0001) and Tal-D (HR, 0.33; 95% CI, 0.24-0.46; p <0.0001). 2 At 24 months, Tal-DP showed a PFS rate of 81.3% and Tal-D showed a PFS rate of 77.6%. 2 All participants (N=864) were previously exposed to lenalidomide and a proteasome inhibitor and received at least one prior line of therapy. 2 Most patients enrolled were refractory to lenalidomide (85.1%) and their last line of therapy (93.4%), and some were exposed to an anti-CD38 antibody (11.8%). 1 Statistically significant improvements compared to DPd were observed across key secondary endpoints of overall response rate (ORR), complete response or better (≥CR) and minimal residual disease (MRD)-negative ≥CR (10 -5 , next-generation sequencing [NGS]) for Tal-DP and Tal-D. 2 ORRs (88.2%, 88.5%, 77.6%), ≥CR rates (71.1%, 68.9%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively, after two years median follow-up. 2 Clinically meaningful improvement in overall survival (OS) was shown with Tal-DP (HR, 0.47; 95% CI, 0.30-0.73; p =0.0006) and Tal-D (HR, 0.51; 95% CI, 0.33-0.78; p =0.0015) vs DPd. 2 At 24 months, Tal-DP delivered an OS rate of 89.2% and Tal-D delivered an OS rate of 87.9%. 2 Safety profiles consistent with the known safety profiles of each monotherapy The overall safety profiles for the talquetamab plus daratumumab treatment arms were consistent with the known safety profiles of each monotherapy. 2 Overall, rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable across treatment arms (94.9% with Tal-DP, 74.8% with Tal-D and 91.5% with DPd). 1 Infections occurred at rates of 87.3% (Tal-DP), 84.3% (Tal-D) and 83.0% (DPd). 2 Tal-D had the lowest rate of Grade 3/4 infections (29.2%), followed by Tal-DP (37.7%) and DPd (42.2%). 2 There were some instances of Grade 5 adverse events (AEs) across the entire population of the study; the Tal-DP arm saw the fewest (1.8%), followed by Tal-D (4.0%) and DPd (4.6%), with approximately 0.7% (Tal-DP), 1.5% (Tal-D) and 1.8% (DPd) due to infections. 1 Treatment discontinuations due to AEs occurred in 10.5% of Tal-DP, 8.0% of Tal-D and 6.7% of DPd patients. 2 At data cutoff; 70.3% (Tal-DP), 69.7% (Tal-D) and 47.3% (DPd) of patients remained on study treatment. 2 About the MonumentTAL-3 Study The MonumenTAL-3 ( NCT05455320 ) study is an ongoing Phase 3 study of talquetamab in combination with daratumumab subcutaneous (SC) with or without pomalidomide compared to daratumumab SC combined with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy. 5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include overall response rate (ORR), complete response or better (≥CR), minimal residual disease (MRD)-negative ≥CR (10 -5 by next-generation sequencing), overall survival (OS) and safety. 5 The MonumenTAL-3 study is a part of the MonumenTAL clinical programme, which includes exploring the potential of talquetamab as a combination regimen. 5 About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. 6 The U.S. FDA also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. 7 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors. 6 To date, more than 11,000 patients have been treated with talquetamab worldwide. 8 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics . In line with the European Medicine Agency’s regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. ▼ In line with EMA regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. 6 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide. 9 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 10 , 11 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 11 , 12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 11 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 11 , 13 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 11 Daratumumab may also have an effect on normal cells. 11 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 For further information on daratumumab, please see the Summary of Product Characteristics at: . About Multiple Myeloma Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 24 , 25 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 26 , 27 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died. 28 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 29 , 30 , 31 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 32 About Johnson & Johnson’s Multiple Myeloma Portfolio Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. Through ongoing research and a robust clinical programme, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MonumenTAL-3 clinical trial TALVEY Talquetamab Talquetamab plus daratumumab Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment END References: 1 Mina R, et al. MonumenTAL-3 Investigators. Talquetamab–Daratumumab in Relapsed or Refractory Myeloma. New England Journal of Medicine. 2026;395(7):671-683. 2 Voorhees P, et al. Phase 3 randomized study of talquetamab (TAL) plus daratumumab (DARA) ± pomalidomide (POM) vs DARA plus DOM ad dexamethasone (DPD) in relapsed/refractory multiple myeloma (RRMM): MonumenTAL-3. Presented at: 2026 European Hematology Association Congress; June 13, 2026; Stockholm. 3 Chari A, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24). 4 Verkleij C, et al. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. Blood. 2021;5(8):2195-2215. 5 ClinicalTrials.gov. MonumenTAL-3: Study of talquetamab in combination with daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed or refractory multiple myeloma (NCT05455320). Available at: . Last accessed: October 2026. 6 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: . Last accessed: October 2026. 7 FDA. FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. Available at: . Last accessed: October 2026. 8 J&J Data on File. Number of Patients Treated with TALVEY ® worldwide as of March 2026. 9 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of August 2026. 10 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: October 2026. 11 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: October 2026. 12 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 13 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 14 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 15 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. 16 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 17 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 18 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 19 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 20 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 21 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 22 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 23 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 24 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 25 Myeloma UK. What is myeloma? Available at: . Last accessed: October 2026. 26 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 27 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: October 2026. 28 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: October 2026. 29 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 30 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 31 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 32 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: October 2026. CP606521 October 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com